Gabapentin lawsuits: Please don't email or call Claudia, the information is in the following links:
WHAT IS GABAPENTIN?
Gabapentin (Neurontin) is a seizure medication that has been promoted for off-label use as an opioid sparing medication. Interestingly, the updated draft of the CDC Guidelines mentions Gabapentin 30 times. 30. Pfizer, maker of this drug, is a a huge donor to CDC Foundation. Is that why they mention it so often in the new guidelines? Who knows?
HARMS FROM GABAPENTIN (NEURONTIN)
Read Dr. Josh Bloom's article "The Devil You Know - Neurontin's Massive Flop as an Opioid Alternative"for more information.
"Wanna hear something sickening? Neurontin, a drug developed for epilepsy and used off-label for neuropathic pain, had its sales grow 250% between 2004 and 2019. Why? We don't have 250% more epileptics. No, it's because the drug is being forced down the throats of people who can no longer get sufficient pain relief. The result? Abuse and also more overdose deaths. Just another chapter in our psychotic war against legitimate opioid drugs and the people who need them."
CLAUDIA'S TIK TOK VIDEOS ABOUT GAPABENTIN (NEURONTIN)
Check out the other Tik Toks on our new main Tik Tok account thedoctorpatientforum1
Our old account is Claudia A. Merandi
LAWSUITS FOR THOSE HARMED BY GABAPENTIN (NEURONTIN)
Please don't email or call Claudia regarding the lawsuits.
The information is in the following links:
"Gabapentin and Neurontin deaths and injuries dramatically increased recently. Contact us to report your injuries and get help. Free case evaluation. Fill out the form on this page or call 424-245-5505. You don’t pay for attorney fees until we win.
If you have lost a loved one or you have suffered from breathing or heart problems or other issues like memory loss and blurry vision, contact us to report exactly what has happened. Free case evaluation.
In a recent article published May 13, 2022 by the Center for Disease Prevention, “Trends in Gabapentin Detection and Involvement in Drug Overdose Deaths — 23 States and the District of Columbia, 2019–2020“, research scientists reported that there are many serious new developments in serious side effects and death resulting from gabapentin use. Contact us for a free case evaluation."
HAS THERE EVER BEEN OTHER LAWSUITS ABOUT GABAPENTIN?
Yes, in 2004 Pfizer agreed to $190 million settlement over generic Neurontin.
Interestingly, this lawsuit was used to create the Attorney Generals' prescriber and consumer education grant. This grant was then used to create Pharmed Out by PROP member, anti-opioid zealot, and expert witness profiteer Adrianne Fugh-Berman.
Dr. Jeffrey Singer debated Dr. Fugh-Berman in June 2022. Read about the debate in this article called "A Surgeon and a Non-Practicing Anti-Opioid Zealot Walk Into a Bar: The Singer and the Fugh-Berman Debate." Then, oddly enough, PROP declared Fugh-Berman the winner when she wasn't. The head of the debate, Gene Epstein, wasn't thrilled and tweeted about it.
Another interesting tidbit about Fugh-Berman, is she was asked to testify at the McGaskill hearing about her first investigation into opioids. Here, Fugh-Berman didn't declare a COI of being a paid expert witness in litigation and told McGaskill that to solve the opioid crisis, they needed to investigate "fake pain advocacy orgs" and their ties to opioid pharma. They did. Many of the lawyers who donated to McGaskill turned around and used her investigation to participate in opioid litigation. The investigation was key in opioid litigation, and many of her PROPcolleagues benefitted financially such as Andrew Kolodny and Anna Lembke. But, they claim anyone who stands up for CPP's must be industry funded. What a scam.
Now let's watch Fugh-Berman push back when Dr. Stefan Kertesz presented his study on suicides due to cutting off opioids from CPP's.
WILL THERE BE A PODCAST ABOUT GABAPENTIN?
Yes, and we plan to interview Dr. Josh Bloom along with some other experts. We will post it here when it is published. Check out the other podcasts by The Doctor Patient Forum.
By: Chad D. Kollas MD, Terri A. Lewis PhD, Beverly Schechtman and Carrie Judy“I'm present. Uh … I do have a conflict. I receive funding to conduct reviews on opioids, and I'll be recusing myself after the um, director's, uh, um, um, uh… update.”- Dr. Roger Chou, Center for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) Board of Scientific Counselors (BSC) Meeting Friday, July 16, 2021.IntroductionFor those familiar with the controversial relationship between the anti-opioid advocacy group, Physicians for Responsible Opioid Prescribing (PROP, recently renamed, Health Professionals for Responsible Opioid Prescribing), and the Centers for Disease Control’s CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016, (2) (hereafter called “the 2016 Guideline”), Dr. Roger Chou’s disclosure represented a stunning admission (3, 4). Chou had originally announced his intention to help influence opioid policy in a 2011 article that he co-authored with PROP’s founders (5), and he was a bold signatory to PROP’s 2012 Petition to the Food and Drug Administration (FDA) to change opioid labeling (6; See Figures 1a and 1b: First page and signatory page.)
Word and pdf of this information
Some CPP advocates created this Community Sign-On Letter for anyone who'd like to sign. Please sign this as well as submitting your own comment on the docket.
****We list some suggestions for you, but please don't use these suggestions word for word. If you do, there is a good chance the CDC will remove your comments.****
The CDC lists the "commenter's checklist." The checklist includes the following:
A comment can express simple support or dissent for a regulatory action. However, a constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision making.
These tips are meant to help the public submit comments that have an impact and help agency policy makers improve federal regulations.
After submission, your comment will be processed by the agency and posted to Regulations.gov. At times, an agency may choose not to post a submitted comment. Reasons for not posting the comment can include:
Organizations often encourage their members to submit form letters designed to address issues common to their membership. Organizations including industry associations, labor unions, and conservation groups sometimes use form letters to voice their opposition or support of a proposed rulemaking. Many in the public mistakenly believe that their submitted form letter constitutes a "vote" regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence rather than a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters.
* Throughout this document, the term "Comment" is used in place of the more technically accurate term "Public Submission" in order to make the recommendations easier to read and understand.
Disclaimer: This document is intended to serve as a guide; it is not intended and should not be considered as legal advice. Please seek counsel from a lawyer if you have legal questions or concerns."
Sometimes it's hard to know what to say. We created some basic comment ideas.
In case you would like some suggestions on what to say in your comments, here are some ideas:
OTHER ARTICLES ABOUT THE UPDATED/EXPANDED CDC GUIDELINES
Many media outlets covered this story. Our favorite is from Josh Bloom "Panic in PROPville."
Here is an article from Pain News Network called "Why CDC Dropped One-Size-Fits-All Approach to Pain Care":
By Pat Anson, PNN Editor
The reaction from patients, advocates and the medical community to a revised draft of the CDC’s opioid guideline has largely been positive, with many cheering the flexibility it gives doctors in deciding whether to prescribe opioids for pain.
Although voluntary and only intended for primary care physicians, the original 2016 guideline’s dose limits became hard thresholds for doctors in all specialties, who feared scrutiny from regulators and law enforcement if they didn’t follow them. The revised draft still recommends caution when prescribing opioids, but emphasizes that physicians should use their own judgement.
“Treating pain is complex. There are a variety of factors at play. And we know that patients respond differently to different types of pain. We tried to incorporate that nuance so that we’re not coming out with something that’s a one-size-fits-all. It really needs to be individualized and flexible,” said Christopher Jones, PharmD, Acting Director of the CDC’s National Center for Injury Prevention and Control.”
People who’ve been closely following the guideline process were surprised at how extensive the changes are. At a July 2021 public meeting, an independent panel advising the CDC expressed alarm that the agency seemed intent on keeping a recommendation that opioid doses be limited to no more than 90 morphine milligram equivalents (MME) per day.
In the last six months, that dose threshold was taken out of the revised draft, which was published Thursday in the Federal Register.
“It was exciting to open up the draft and see a significant pivot,” said David Dickerson, MD, who chairs the American Society of Anesthesiologists’ Committee on Pain Medicine. “I think the CDC authors have acknowledged that they wanted to do it different this time.”
Dickerson was not only pleased to see the 90 MME threshold go away, but a stronger focus on the many different types of pain, whether its temporary acute pain from surgery or chronic pain from a disabling, incurable disease.
“I think the text of this manuscript is really well done in its draft form right now. When I read through it, it was a great refresher and highlighted some studies that perhaps I had missed,” Dickerson told PNN. “They are instructive, they’re specific, but they also have an intentional vagueness to them to allow for clinicians to practice medicine.”
Importantly, the guideline also makes clear that it shouldn’t be used by third parties to dictate how pain should be treated.
“This voluntary clinical practice guideline provides recommendations only and is intended to be flexible to support, not supplant, clinical judgment and individualized, person-centered decision-making. This clinical practice guideline should not be applied as inflexible standards of care across patient populations by healthcare professionals, health systems, pharmacies, third-party payers, or state, local, and federal organizations or entities.”
“States and insurers have turned the guideline into laws and unbending regulations, preventing physicians from treating patients as individuals with specific needs,” Bobby Mukkamala, MD, Chair of the American Medical Association’s Board of Trustees, said in a statement. “The list of misapplications of the 2016 guideline is long, and its impact has been tremendous harm.
“The CDC’s new draft guideline — if followed by policymakers, health insurance companies and pharmacy chains — provides a path to remove arbitrary prescribing thresholds, restore balance and support comprehensive, compassionate care.”
Nearly 40 states have codified the 2016 guideline in some way, often by limiting the number of opioid pills that can be dispensed for an initial prescription to seven days’ supply or less. Dickerson hopes those states will review and revise their laws and regulations to better reflect what the CDC recommends in its revised draft – that enough opioids be prescribed for “the expected duration of pain.”
“We should right-size our care for the individual patient and be procedure specific. Before it was one-size-fits-all, three to seven days’ (supply),” Dickerson said.
He also thinks the Department of Justice (DOJ) and Drug Enforcement Administration (DEA) should reconsider their aggressive prosecution of doctors for prescribing high doses.
“The work that the DOJ and DEA is doing, I want to believe is done in good intent,” he said. “I think that many of their cases will look at the prescriptions or the doses, but they might not look at the context for why the patient was receiving that care or why they were receiving those medicines.”
The CDC is not expected to finalize its draft guideline until late this year. You can read the guideline and leave an online comment in the Federal Register. Comments must be received by April 11.